MaxGuard ME1046Recalls & reported problems
BD Switzerland Sàrl · T-Connector Extension Set, (minibore) with injection Site 10.2cm (4 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403235986), received between Jun 18, 2019 and Apr 9, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Difficult or Delayed Separation1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2021Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation
IT WAS REPORTED THAT 1 4 IN MINIBORE SET W/ T-CONNECTOR & INJ SET FROM LOT 20087364, 1 SET FROM AN UNSPECIFIED LOT WERE DIFFICULT TO DISCONNECT FROM THE IV TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE BACK TO THE OLD T-TUBES AGAIN ON THE PIXS. #870254. THESE WERE THE ONES THAT WE HAD PROBLEMS GETTING THEM DISCONNECTED FROM THE IV TUBING AND WE GOT OUR OLD ONES BACK AND WE DID NOT HAVE PROBLEMS." "USES A BD T-CONNECTOR EXTENSION SET ME1046 IN OUR NICU, AND WE HAVE BEEN HAVING A REAL STRUGGLE WITH THE PRODUCT NOT DISCONNECTING EASILY FROM IV TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646034 ↗MalfunctionJun 18, 2019Break; Break
IT WAS REPORTED THAT THE EXTENSION SET BROKE OFF IN THE T-CONNECTOR DURING THE ADMINISTRATION OF RBCS WHILE CONNECTED TO A NEONATE. THEY WERE UNABLE TO REMOVE THE BROKEN PIECE SO THEY REPLACED THE T-CONNECTOR. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8707431 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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